BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROBASICS

    MDR report key: 16592266 · Received March 22, 2023

    Report

    Report Number
    3012316249-2023-00004
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    October 4, 2022
    Report Date
    March 22, 2023
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DAUGHTER WAS BEING ASSISTED IN LIFT AND IT FELL TO GROUND IN OCTOBER. LIFT FAILED AND FELL ON TOP OF HER. HAD TO HAVE SURGERY THE NEXT DAY. LIFT WON'T STAY UP AND WHEEL/ CASTER IS BROKEN. AT HOME WHEN THIS HAPPENED. HAPPENED EITHER ON (B)(6) 2022. BROKE HER FEMUR. HAD MAJOR SURGERY - PINS AND RODS. SAID SHE FELL TO THE FLOOR AND IT FELL ON TOP OF HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843041 PROBASICS Lift, patient, non-ac-powered FSA SHENYANG HENYI ENTERPRISE CO., LTD PBPLSM001

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization| R